Albireo AB (Gothenburg, Sweden; "Albireo"), a biopharmaceutical company specializing in gastroenterology, today announced that the European Medicines Agency Committee for Orphan Medicinal Products (COMP) has issued a positive opinion on an application for orphan medicinal product status for the company's lead hepatology candidate, A4250, for the treatment of:
- Primary Biliary Cirrhosis (PBC)
- Progressive Familial Intrahepatic Cholestasis (PFIC)
- Alagille Syndrome
The positive opinion of the COMP has now been forwarded to the EU commission for final approval. The designation would allow Albireo ten years of marketing exclusivity in EU member countries after obtaining market authorization, as well as streamlined regulatory review processes and registration.
"We are very pleased with the EMA´s recognition of our technology with A4250 as an orphan medicinal product for the treatment of these liver diseases in Europe", said Dr. Hans Graffner, Chief Medical officer at Albireo. "This designation is an important milestone in our efforts to provide a treatment for patients with cholestatic liver diseases; a disease entity often leading to severe symptoms, liver transplantation and with reduced survival. A4250 is an inhibitor of the bile acid transport mechanism and will decrease the toxic levels of bile acids in the liver cells."